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IDRX-42 · 2 trials · 5 indications
PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| IDRX-42 (GSK6042981) | EXPERIMENTAL | - |
| Sunitinib | ACTIVE_COMPARATOR | - |
| Dose Escalation (Phase I) | EXPERIMENTAL | Participants should have advanced (metastatic and/or surgically unresectable) GIST, following failure of at least prior imatinib therapy due to progression of GIST. |
| (Phase 1b) Cohort 1 - Participants with GIST progression after first-line imatinib therapy | EXPERIMENTAL | Participants with advanced GIST who have had GIST progression after first-line imatinib only (second line therapy setting) and refused or are ineligible for other standard of care (SOC) therapies. |
| (Phase 1b): Cohort 2 - Participants with GIST progression after 2 or more lines of TKI therapy | EXPERIMENTAL | Participants with metastatic and/or surgically unresectable GIST following progression EITHER after sequential imatinib then sunitinib (third-line therapy setting) OR after imatinib, sunitinib, and then an additional TKI agent (i.e., regorafenib or ripretinib) (fourth-line therapy setting) OR after imatinib, sunitinib, regorafenib, and ripretinib (5th line or greater therapy). |
| (Phase 1b): Cohort 3 - Participants with GIST who are treatment naïve | EXPERIMENTAL | Participants with metastatic and/or surgically unresectable GIST who are treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies. |
| (Phase 1b): Cohort 4 | EXPERIMENTAL | Participants with GIST progression who meet the same criteria as Cohort 2 (third line or greater TKI therapy) and have had prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination. |
| Name | Type | Description |
|---|---|---|
| IDRX-42 | DRUG | IDRX-42 will be administered. |
| Sunitinib | DRUG | Sunitinib will be administered. |
Inclusion Criteria: * Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable. * Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease. * Documented mutation st...
IDRX-42 is an investigational small molecule being developed for gastrointestinal neoplasms, specifically gastrointestinal stromal tumors (GIST). It is studied in patients with metastatic and/or unresectable GIST, and in a Phase 3 trial for GIST after imatinib therapy. It is not yet approved and remains in clinical development.
IDRX-42 is a small molecule designed to target specific molecular pathways involved in gastrointestinal stromal tumors. The exact molecular target is not disclosed in the available information, but it is being studied in biomarker-selected patients, suggesting it acts on a defined genetic alteration driving tumor growth.
IDRX-42 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of IDRX-42 in patients with gastrointestinal stromal tumors.
IDRX-42 is currently in Phase 3 clinical development. A Phase 3 trial is recruiting participants to compare IDRX-42 (also known as GSK6042981) against sunitinib in patients with gastrointestinal stromal tumors after imatinib therapy. An earlier Phase 1 first-in-human study is also ongoing.
IDRX-42 is being studied in two active clinical trials. NCT05489237 is a Phase 1 first-in-human study in participants with metastatic and/or unresectable gastrointestinal stromal tumors, enrolling 278 patients. NCT07218926 is a Phase 3 trial comparing IDRX-42 to sunitinib in GIST patients after imatinib, enrolling 450 patients.
Yes, IDRX-42 is also known as GSK6042981. The Phase 3 clinical trial NCT07218926 refers to the drug as IDRX-42 (GSK6042981), confirming that both names refer to the same investigational compound being developed by GSK.